WASHINGTON – A top government health official yesterday rejected pediatricians' calls for an immediate ban on over-the-counter cough and cold medicines for young children, saying it might cause unintended harm.
But Food and Drug Administration officials at a public hearing also said they were uncomfortable with the lack of solid scientific data to support continued use of such remedies with youngsters, particularly those ages 2 to 6.
A ban – as sought by leading pediatrician groups – might only drive parents to give adult medicines to their youngsters, said Dr. John Jenkins, who heads the FDA's Office of New Drugs.
“That is a concern for us,” Jenkins said. “We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation.”
With a new cold season coming, pediatricians are urging the government to demand a recall of over-the-counter cough and cold medicines for children younger than 6. The effectiveness of the medicines in children was never proved, and problems with the drugs send thousands of youngsters to the emergency room every year, critics said.
“When a treatment is ineffective, its risks – unless zero – always exceed its benefits,” Dr. Michael Shannon of Children's Hospital in Boston told the FDA panel.
The FDA's Jenkins said, “We don't see a public health emergency here as far as an inherent risk of the products.”
But he agreed with critics who say there's no proof that the medicines work in children. “We don't see that adequate evidence of efficacy has been demonstrated in children to date,” Jenkins said. Clinical studies to try to settle the issue could take years to complete and may not provide clear answers.
“It really is a conundrum for us,” Jenkins said.
Parents also might be frustrated by the conflicting advice.
The American Academy of Pediatrics says that over-the-counter products are ineffective for treating coughs and colds in children under 6 and shouldn't be given because of the risk of serious side effects – a conclusion seconded last year by a panel of outside advisers to the FDA. But the FDA's own advice is that parents should not give the medications to tots under 2 – a position shared by the drug companies.
In January, FDA officials said they expected to decide by spring on recommendations for children up to 11. Now the agency is seeking more advice from doctors, industry and consumers – and officials are not giving a timetable for a decision.
U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week, the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2-to 5-year-olds, a recent Boston University report found.
But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.
The industry says over-the-counter medicines have been used for decades in treating children's colds and are safe for those older than 2. Nonetheless, manufacturers are planning to carry out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.
It turns out that when the FDA set standards about 30 years ago, no separate studies were done for children.
